The HealthTech Activator and Te Tītoki Mataora are pleased to host our first workshop on the regulation requirements for Software as a Medical Device (SaMD) products. This one-day, compact workshop aims to increase your competence in the practical implementation of regulatory requirements (in particular, IEC 62304) while promoting efficient software development. It is an introduction to the topic of development, quality assurance and approval of medical software (software as a medical device or medical device software).
This workshop will help you:
- Regulatory basics: Know the relevant guidelines, directives, laws, standards, regulations and their interaction
- Process: Know the development activities of the IEC 62304 and how to match agile development with this standard
- Documentation: Create lean and accurate documents that meet the requirements of IEC 62304 (e.g. software requirements, software architecture and software design)
- SOUP: Know how to select, integrate and document third-party software in an IEC 62304 compliant manner
- Software risk management: Understand the interaction of risk management according to ISO 14971 and IEC 62304 and the definition of safety classes
- Cyber Security: Understand what the requirements are and how they play into your development process
This will be an interactive workshop with opportunities for discussions and questions, so come ready to participate!
Hosted by:
Annett Arndt:
Anne started her career as a software developer over 20 years ago, eventually working as a consultant on software projects in the food industry. On leaving the field of software development Anne changed to quality and process management, and for the last 10 years has worked successfully on the approval of medical products in Europe.
Anne joined the Johner Institute four years ago and since then has successfully supported customers in the approval of medical devices with a focus on software as a medical device. Subsequently, Anne moved from Europe to New Zealand and together with a European manufacturer, she took advantage of the 12-hour time difference and worked with a team 24 hours a day to launch a Covid tracking app onto the market after two months of successful cooperation.
In 2021, Anne was appointed as Director of Johner Institute New Zealand, and now supports clients in New Zealand and Australia in preparing their products for global approval. Anne’s focus remains on active medical devices including software. Her passion for regulatory compliance drives her to also support suppliers to medical device manufacturers, for example helping software developers and testers to understand the development of products following a regulatory framework."
